ChemDiv chemistry of cures

ChemDiv has the chemical equipment and experienced personnel to scale up the Active Pharmaceutical Ingredients (API) to meet all regulatory requirements suitable for administration to human subjects. The state of the art facility can handle quantities up to several kilograms and has the full capability to conduct purity and stability analysis. We offer extensive pre-formulation and biopharmaceutical support between candidate identification and clinical development.

Preformulation

These services include solid characterization, solution characterization, excipient compatibility, accelerated stability, chiral stability.

Formulation

ChemDiv has capabilities in formulation development for dosage forms, troubleshooting and process development of existing dosage forms, optimization of existing formulations, and qualitative/quantitative evaluation of proprietary dosage forms. Dosage forms include solids (tablets, capsules, sustained release and coatings), semi-solids (ointments, creams, gels), dispersed systems (emulsions, suspensions), and liquids (orals, ophthalmic).

Analytical

Analytical capabilities include method development, qualification and validation, raw material testing, stability sample analysis, dissolution testing, residual solvent analysis, chiral determination, cleaning evaluations, and technical packages for drug substances.

Manufacturing

Clinical supplies manufacturing capabilities include API into capsule, tablets and capsules, liquid in capsule, semi-solids, and non-sterile liquid. In addition, we provide reference product blinding, packaging and labeling services, and offer expertise in creation of matching placebo formulation, creation and qualification of blinded reference product, process qualification, process definition optimization, and technology transfer.

Stability

ChemDiv gathers information from our clients to establish the correct parameters of our stability studies, including appropriate test conditions, the duration of the stability study, the testing intervals, and the analytical methods. These processes vary with the type of product and type of study, scientific or regulatory, and ChemDiv has extensive experience with both.

Generics Activity

• TOP 200 brand monitoring information about drugs patent expiration
• Search and selection of APS suppliers according to customers requirements
• APS analytical methods development and validation  according to national pharmacopoeia
• Calculation of direct manufacture cost
• Final drugs formulation
• Technology transfer and process control on customer's production space

CMC Support

To read about our strategic design of an integrated CMC development plan, click here.
The Global Project manager oversees the all parts of CMC plan development and execution. We will also provide development support to cover early phase development (Phases I and II) in addition to designing drug substance, drug product and process.